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Executive Summary

FDA LEADERSHIP IN CLINICAL TRIAL COMPUTER SIMULATION URGED in the Institute for Alternative Future's "Clinical Development 2005" report discussed at a Capitol Hill briefing July 18. "Advances in computer simulation can contribute significantly to the process of clinical development," the report declares. Placing FDA in a leadership role to develop the concept "would be a powerful leveraging strategy that would position simulation as a new mechanism in clinical development," the report states.